Cleared Traditional

vascuCAP (K183012) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence.

K183012 · Elucid Bioimaging, Inc. · Radiology device
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Dec 2018
Decision
51d
Days
Class 2
Risk

K183012 is an FDA 510(k) clearance for the vascuCAP. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Elucid Bioimaging, Inc. (Wenham, US). The FDA issued a Cleared decision on December 21, 2018 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Elucid Bioimaging, Inc. devices

Submission Details

510(k) Number K183012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2018
Decision Date December 21, 2018
Days to Decision 51 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 107d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02143102 Completed Observational Industry-sponsored

Non-invasive Computer-Aided Phenotyping of Vasculopathy

vascuCAP: Non-invasive Computer-Aided Phenotyping of Vasculopathy

125
Patients (actual)
2
Sites
Condition studied Carotid Atherosclerosis; Peripheral Arterial Disease
Eligibility All sexes · 18 Years+
Principal investigator Andrew J. Buckler, M.S.
Sponsor Elucid Bioimaging Inc. (industry)
Started 2014-07-01 → Primary completion 2017-03-14 → Completed 2017-06-30
Primary outcome
Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.
View full study on ClinicalTrials.gov

Regulatory Peers - LLZ System, Image Processing, Radiological

All 799
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K183012.
iSchemaView RAPID
K182130 · Ischemaview, Inc. · Dec 2018
Quantib ND
K182564 · Quantib B.V. · Dec 2018
4D View
K182750 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Dec 2018
3DIEMME RealGUIDE
K173041 · 3Diemme , Ltd. · Dec 2018
MIM - MRT Dosimetry
K182624 · Mim Software, Inc. · Dec 2018
Centricity Universal Viewer
K182419 · Ge Healthcare · Dec 2018